API Lead
Ge Healthcare, Orslow, Staffordshire
API Lead
Salary not available. View on company website.
Ge Healthcare, Orslow, Staffordshire
- Full time
- Permanent
- Remote working
Posted today, 5 Nov | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
Job ref: 7b2135980d444c15b4baa423b08b5001
Location ref: Orslow, Staffordshire
Full Job Description
- Lead the development and manufacturing of APIs, precursors, and key materials at external CMOs from early development through commercialization.
- Act as the primary technical interface between internal project teams, CMOs, key suppliers, and other external development and manufacturing partners.
- Define development strategies, deliverables, timelines, risks, and priorities, and oversee process development, optimization, scale-up, technology transfer, and GMP manufacturing.
- Contribute to assessing selecting, qualifying, and onboarding CMOs and key suppliers based on technical capabilities, capacity, quality, cost, timelines, and risk, and monitor ongoing performance.
- Lead technical, quality, and manufacturing challenges, including deviations, investigations, change controls, and impurity-related issues.
- Define API starting material, characterization, and impurity-control strategies, including regulatory justification in line with applicable ICH guidelines.
- Prepare and review CMC documentation for manufacturing activities, and regulatory submissions.
- Collaborate across Quality, Regulatory, Analytical Development, Manufacturing, Supply Chain, Sourcing, IP, Legal, and project teams to ensure compliant execution in line with applicable GMP, regulatory, quality, and EHS requirements.
PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, or a related scientific or engineering discipline. - Relevant experience in API, precursor, or pharmaceutical process development, including process development, scale-up, technology transfer, or manufacturing.
- Demonstrated experience managing CMOs or outsourced pharmaceutical development and manufacturing activities.
- Strong knowledge of GMP requirements, pharmaceutical development, and regulatory CMC expectations.
- Strong technical understanding of API characterization, analytical method development, impurity investigations, and impurity-control strategies.
- Experience preparing or supporting CMC documentation for regulatory submissions and health-authority interactions.
- Excellent written and verbal communication and stakeholder-management skills, with the ability to influence decisions and manage competing priorities in cross-functional and multicultural environments.
- Fluent in English, both written and verbal. Behaviors We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. GE HealthCare Pharmaceutical Diagnostics (PDx) is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.
Direct job link
https://www.jobs24.co.uk/job/api-lead-127696189